Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
Dense Deposit Disease, Membranoproliferative Glomerulonephritis
About this trial
This is an interventional treatment trial for Dense Deposit Disease focused on measuring Dense deposit disease, C3 nephropathy, Eculizumab
Eligibility Criteria
Inclusion Criteria:
- Adult patients with biopsy proven DDD or C3 nephropathy, at least 18 years of age
- 24-hour urine protein > 1000 mg/day, urine protein:creatinine ratio > 1.0, or acute renal failure (defined as > 50% increase in serum creatinine from baseline)
- Willing and able to sign informed consent
- Patients of childbearing age must agree to use birth control
- Patients must be willing to be vaccinated against meningococcal disease or have documentation of previous vaccination against meningococcal disease
Exclusion Criteria:
- Patients under 18 years of age
- Patients unable to sign informed consent
- Patients having received rituximab or another monoclonal antibody within 6 months of the trial
- Patients currently taking and unable to discontinue other immunomodulatory therapies (e.g. cyclosporine, high-dose steroids, mycophenolate mofetil) unless these other therapies are indicated for prophylaxis of transplant rejection (e.g. stable doses of mycophenolate mofetil and/or calcineurin inhibitor). Patients on chronic steroid therapy who are unable to taper down to <10 mg/day will be excluded.
- Patients of childbearing age who refuse to use birth control
- Patients with a baseline estimated GFR less than 30 ml/min/1.73m2
- Patients with other renal diseases (e.g. diabetic nephropathy, renal vascular disease) that would interfere with interpretation of the study.
- Patients with comorbid conditions that would interfere with completion of the trial (malignancies, congestive heart failure (CHF), recent myocardial infarction).
- Patients with known contraindications to the use of eculizumab, including refusal to receive N. meningitides vaccine prior to therapy
Sites / Locations
- Columbia University Medical Center, Glomerular Center
- Columbia University Medical Center, Nephrology Clinical Research Center
Arms of the Study
Arm 1
Experimental
Eculizumab
Patients will receive Eculizumab and be observed for 60 minutes after the first 5 infusions, then 30 minutes after all subsequent infusions. Patients will not be allowed to take other immunomodulatory therapies during the study period but will continue on their other non-immunomodulatory therapies (e.g. ACE inhibitors, -statins, aspirin) without modifications unless clinically indicated. All patients, if unvaccinated, will be given N. meningitides vaccine at least two weeks prior to first eculizumab exposure. All female patients of childbearing potential will be asked to use adequate contraception methods during treatment and up to 5 months following discontinuation of eculizumab treatment.